If needed, you may use your free hand to stabilize the applicator. If Nexplanon is inserted deeply (intramuscular or in the fascia), neural or vascular injury may occur. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Subdermal Use Only. All healthcare professionals should receive instruction and training prior to performing insertion and/or removal of Nexplanon. Although ectopic pregnancies are uncommon among women using Nexplanon, a pregnancy that occurs in a woman using Nexplanon may be more likely to be ectopic than a pregnancy occurring in a woman using no contraception. A broken implant may move from the insertion site. At the latest, Nexplanon … Nexplanon should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding. Investigations: clinically relevant rise in blood pressure, weight decreased. Before inserting Nexplanon, carefully read the instructions for insertion as well as the full prescribing information. After subdermal insertion of the etonogestrel implant, etonogestrel is released into the circulation and is approximately 100% bioavailable. Nexplanon should preferably be inserted on the day after the last active tablet of the previous combined oral contraceptive or on the day of removal of the vaginal ring or transdermal patch. seizure medicine - carbamazepine, felbamate, oxcarbazepine, phenytoin. Nexplanon should be inserted within 24 hours after taking the last tablet. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. All healthcare professionals performing insertions and/or removals of Nexplanon should receive instructions and training prior to inserting or removing the implant. If the implant cannot be found in the arm after a thorough search, your healthcare provider may use x-rays or other imaging methods on your chest. By palpating both ends of the implant, you should be able to confirm the presence of the 4 cm rod (Figure 9). Tell your doctor if you are breast-feeding. Always verify the presence of the implant in the woman's arm immediately after insertion by palpation. Immune system disorders: anaphylactic reactions. Be sure to inject the local anesthetic under the implant to keep the implant close to the skin surface. Consideration should be given to removing Nexplanon in patients who become significantly depressed. Apply a small adhesive bandage over the insertion site. Fertility in rats returned after withdrawal from treatment. There also have been postmarketing reports of implants located within the vessels of the arm and the pulmonary artery, which may be related to deep insertions or intravascular insertion. Counsel women to contact their healthcare professional immediately if, at any time, they are unable to palpate the implant. Insert the needle until the bevel (slanted opening of the tip) is just under the skin (and no further) (Figure 5b). Less than three bleeding and/or spotting episodes in 90 days (excluding amenorrhea), Any bleeding and/or spotting episode lasting more than 14 days in 90 days, More than 5 bleeding and/or spotting episodes in 90 days, Implant located adjacent to fascial tissue, Pins and Needles/Numbness (arm/hand/fingers), Injury to Blood Vessels or Blood Clots in Arm. Ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI) may be used. You may feel slight resistance but do not exert excessive force. Step 6. Injectable Contraceptives: Insert Nexplanon on the day the next injection is due. Step 10. Once the implant is removed, from whichever method, it is important to not neglect the incision area are read the signs if any, the body gives post the removal … Additionally, hematoma (3.0%), bruising (2.0%), pain (1.0%), and swelling (0.7%) were reported. In case of undiagnosed, persistent, or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. If the needle is not inserted to its full length, the implant will not be inserted properly. Available for Android and iOS devices. Avoid storing Nexplanon at temperatures above 30ºC (86ºF). Anesthetize the site, for example, with 0.5 to 1 mL 1% lidocaine, where the incision will be made (Figure 11). Mirena contains 52 mg of levonorgestrel (LNG). Step 10. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. This location is intended to avoid the large blood vessels and nerves lying within and surrounding the sulcus (See Figures 2a, 2b and 2c). Nexplanon also thickens the mucus in your cervix and this change may keep sperm from reaching the egg. The contraceptive effect of Nexplanon is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium. If the cap does not come off easily, the applicator should not be used. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. What are the possible risks of using Nexplanon? Do not move the applicator while moving the purple slider (Figure 8b). Based on. The use of combination hormonal contraceptives (progestin plus estrogen) increases the risk of vascular events, including arterial events (strokes and myocardial infarctions) or deep venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). It is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure because these reactions are reported voluntarily from a population of uncertain size. Etonogestrel can pass into breast milk, but effects on the nursing baby are not known. In studies, 2.3% of the users reported weight gain as the reason for having the non-radiopaque etonogestrel implant removed. Apply a pressure bandage with sterile gauze to minimize bruising. Lower the applicator to a nearly horizontal position. If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow beyond the size it would attain in a normal cycle. Some studies suggest that the use of combination hormonal contraceptives might increase the incidence of breast cancer; however, other studies have not confirmed such findings. • Changes in Menstrual Bleeding Patterns (menstrual periods). Based on the findings of this study, during the first months after insertion of IMPLANON, when maternal blood levels of etonogestrel are highest, about 100 ng of etonogestrel may be ingested by the child per day based on an average daily milk ingestion of 658 mL. Check the applicator. This product has not been studied in women over 65 years of age and is not indicated in this population. Safety and efficacy of Nexplanon have been established in women of reproductive age. Another positive is the IUD’s flexibility in removal. If the implant is located in the chest, surgical or endovascular procedures may be needed for removal; healthcare professionals familiar with the anatomy of the chest should be consulted. Last updated on Nov 4, 2020. At the time of implant removal, eighteen implants (0.4% of all localizations or removals) were not palpable by the healthcare professionals. The single, non-palpable implant was not inserted according to the instructions. The woman does not have allergies to the antiseptic and anesthetic to be used during insertion. Implants, such as Nexplanon and Implanon, cost over $800 each. From the side view (see. Radiopaque Use of Nexplanon in women with active liver disease or liver cancer is contraindicated [see Contraindications (4)]. If needed, gently remove adherent tissue from the tip of the implant using blunt dissection. Table 6 provides a summary. It does not protect Use other methods to confirm the presence of the implant. Copyright 1996-2021 Cerner Multum, Inc. A postmarketing prospective active surveillance study was conducted among 7,364 patients in the United States to characterize the frequency of insertion-, localization-, and removal-related events. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. An implant containing etonogestrel is a … However, we limit walk-ins after 4pm every day, and it gets stricter on … Before removal of the implant, the healthcare professional should confirm that: The following equipment is needed for removal of the implant: For illustrative purposes, Figures depict the left inner arm, Step 1. • Switching contraceptive method to Nexplanon. Your risk of stroke or blood clot is highest during your first year of using this medicine. If the purple slider is released prematurely, restart the procedure with a new applicator. (etonogestrel implant) 68 mg No adverse development outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses of 315 or 781 times the anticipated human dose (60 µg/day) (see Data). Do not push the protruding implant back into the incision. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Complications of insertion and removal — Fitting and removing the implant requires a minor surgical procedure and may cause some pain, ... Depression and mood changes. Adverse Reactions and Events from Postmarketing Study, Nexplanon Observational Risk Assessment Study (NORA). Planning, making available, and using birth control … If the implant cannot be grasped, stop the procedure and refer the woman to a healthcare professional experienced with complex removals or call 1-877-888-4231. Medically reviewed by Drugs.com. Do not touch the purple slider until you have fully inserted the needle subdermally, as doing so will retract the needle and prematurely release the implant from the applicator. Birth control shot (Depo-Provera) : Depo-Provera is the contraceptive that gives all … Call 1-877-888-4231 for further information. The timing of when you receive the Nexplanon implant depends on whether you were using birth control before, and what type it was. Nexplanon prevents pregnancy in several ways. Immediately after the Nexplanon implant has been placed, you and your healthcare provider should check that the implant is in your arm by feeling for it. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Step 13. Not all possible interactions are listed in this medication guide. If the implant cannot be palpated, it may be deeply located or have migrated. Meritas Health Gashland is a medical group practice located in Kansas City, MO that specializes in Family Medicine. You have an increased chance of getting blood clots during surgery or bed rest. An estimate of the attributable risk is 3.3 cases per 100,000 for combination hormonal contraceptives users. Each implant consists of an ethylene vinyl acetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel, barium sulfate (radiopaque ingredient), and may also contain magnesium stearate, surrounded by an EVA copolymer skin. The health of breast-fed children whose mothers were using the implant has been studied up to 3 years of age in a small number of children. You may need to have a negative pregnancy test before receiving the implant. Have, or have had blood clots, such as blood clots in your legs (deep venous thrombosis), lungs (pulmonary embolism), eyes (total or partial blindness), heart (heart attack), or brain (stroke), Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past. At the latest, Nexplanon should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive. Also, complete the PATIENT CHART LABEL and affix it to the woman's medical record. If you have breast cancer now, or have had it in the past, do not use Nexplanon because some breast cancers are sensitive to hormones. Complete the USER CARD and give it to the woman to keep. The applicator can now be removed (Figure 8c). The study evaluated Implanon versus another contraceptive, was not randomized and data were considered observational and exploratory; therefore, comparisons could not be made. This location is intended to avoid the large blood vessels and nerves lying within and surrounding the sulcus. Gently grasp the implant and then flip the forceps over into your other hand (Figure 17). To help reduce the risk of neural or vascular injury, Nexplanon should be inserted subdermally just under the skin at the inner side of the non-dominant upper arm overlying the triceps muscle about 8-10 cm (3-4 inches) from the medial epicondyle of the humerus and 3-5 cm (1.25-2 inches) posterior to (below) the sulcus (groove) between the biceps and triceps muscles. The implant should be inserted subdermally just under the skin (see Warnings and Precautions (5.1)). Substances increasing the plasma concentrations of HCs: Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including etonogestrel. Clean the skin from the insertion site to the guiding mark with an antiseptic solution. In a clinical trial of Nexplanon, in which investigators were asked to examine the implant site after insertion, implant site reactions were reported in 8.6% of women. After starting Nexplanon, women are likely to have a change from their normal menstrual bleeding pattern. If you are unsure of the necessary steps to safely insert and/or remove Nexplanon, do not attempt the procedure. Some women have dismissed these symptoms as “normal” after the removal … Puncture the skin with the tip of the needle slightly angled less than 30° (Figure 5a). Step 2. Call 1-877-888-4231 for further information. Removal of the implant should only be performed under aseptic conditions by a healthcare professional who is familiar with the removal technique. The exact location of the implant in the arm should be verified by palpation. Step 1. The sterile applicator containing the implant is packed in a blister pack. Other adverse reactions that were reported by at least 5% of subjects in the non-radiopaque etonogestrel implant clinical trials are listed in Table 4. The woman understands the benefits and risks of Nexplanon. Schedule an appointment with your healthcare provider to remove the implant on or before the removal date. Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. The time between periods may vary, and in between periods you may also have spotting. This rate decreases progressively to half that value after … If it does not, gently push the implant towards the incision until the tip is visible. NDC 0052-4330-01 Once inserted subdermally, the release rate is 60-70 mcg/day in week 5-6 and decreases to approximately 35-45 mcg/day at the end of the first year, to approximately 30-40 mcg/day at the end of the second year, and then to approximately 25-30 mcg/day at the end of the third year. After the implant is inserted, your arm will be covered with 2 bandages. Hormonal contraceptives may affect the metabolism of other drugs. If the implant is placed after the fifth day of menses, then you should use an additional contraceptive method (such as a condom) for the first 7 days after insertion. Generic Name: etonogestrel General disorders and administration site conditions: edema, fatigue, implant site reaction, pyrexia. Removal was not attempted for six non-palpable implants due to underlying health conditions, administrative problems, or unspecified reasons. In cases where the implant has migrated to the pulmonary artery, endovascular or surgical procedures may be needed for removal. A woman who is using Nexplanon should have a yearly visit with her healthcare professional for a blood pressure check and for other indicated health care. Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Confirm that the entire implant, which is 4 cm long, has been removed by measuring its length. Perform a pregnancy test before inserting Nexplanon. Some cases of implants found within the pulmonary artery reported chest pain and/or respiratory disorders (such as dyspnea, cough, or hemoptysis); others have been reported as asymptomatic [see Warnings and Precautions (5.1)]. If the implant cannot be found in the arm after comprehensive localization attempts, consider applying imaging techniques to the chest as events of migration to the pulmonary vasculature have been reported. Some cases of implants found within the pulmonary artery were associated with chest pain and/or respiratory disorders (such as dyspnea, cough, or hemoptysis); others were asymptomatic. Some examples of serious blood clots are blood clots in the: The risk of serious blood clots is increased in women who smoke. Advise the patient to read the FDA-approved patient labeling (Patient Information). When it is time to have the implant removed — after 3 years for Nexplanon… The medicine is released slowly into the body. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. If the needle is not inserted to its full length, the implant will not be inserted properly. The woman does not have allergies to the antiseptic or anesthetic to be used. It contains a small amount of barium sulfate so that the implant can be seen by X-ray, and may also contain magnesium stearate.

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